Evidence map›Paper›PMID 24205135›Full record

Trial reportPloS one2013

Comparing tolerability and efficacy of generic versus brand alendronate: a randomized clinical study in postmenopausal women with a recent fracture.

Joop P W van den Bergh, Marian E Bouts, Eveline van der Veer, Robert Y van der Velde, Marcel J W Janssen, Piet P Geusens, Bjorn Winkens, Nico J J Oldenhof, Tineke A C M van Geel

Open access · goldAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in PloS one, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
1.0field-weighted citation impact, top 26% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 1 synthesis or guideline pooled it, 17 citations in OpenAlex.

  1. Eliciting adverse effects data from participants in clinical trials.The Cochrane database of systematic reviews · 2018
    Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Trial
  6. Article
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  8. Observational
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 4 institutions in 2 countries.

Joop P W van den BerghDepartment of Internal Medicine, VieCuri Medical Centre of Noord-Limburg, Venlo, The Netherlands ; Department of Internal Medicine, Maastricht University Medical Centre, Maastricht, The Netherlands ; Maastricht University, NUTRIM - School for Nutrition, Toxicology and Metabolism, Maastricht, The Netherlands ; Biomedical Research Centre, University Hasselt, Diepenbeek, Belgium.
Marian E Bouts
Eveline van der Veer
Robert Y van der Velde
Marcel J W Janssen
Piet P Geusens
Bjorn Winkens
Nico J J Oldenhof
Tineke A C M van Geel
VieCuri Medisch Centrum · NLMaastricht University · NLMaastricht University Medical Centre · NLUniversity Medical Center Groningen · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionAn increasing number of generic alendronate formulations have become available. Although expected to have the same tolerability and efficacy, head-to head comparison of generic and brand alendronate was never performed. Therefore, we compared the tolerability and efficacy of generic and brand alendronate.

methodsIn a randomized double-blinded single centre cross-over study in 37 postmenopausal women (mean age 65.4±6.4 years) with osteoporosis were treated with generic and branded alendronate during 24 (2x12) weeks. Tolerance was evaluated by the Gastro intestinal Symptom Rating Scale (GSRS) and self-reported side effects. Efficacy was assessed by serum bone turnover markers, carboxy terminal telopeptide (CTX) and procollagen type I N-terminal propeptide (PINP). No wash out period was allowed (ethical reasons). Because of possible carry over effect only data of the first 12 weeks were analyzed using linear mixed models.

resultsThere were no significant differences in overall tolerance (GSRS) between treatment groups. However, for subscale abdominal pain, patients using generic had a significantly higher mean GSRS score at week 4 (estimated mean difference (B): 0.40; 95%CI: 0.05 to 0.74, p = 0.024). The level of bone turnover markers significantly decreased over 12 weeks of follow-up for generic and branded alendronate (p < 0.001). Mean level of CTX was significantly lower with branded at week 4 (B: 121.3; 95%CI: 52.0 to 190.5), but not at week 12 (B: 53.6; 95%CI:-3.7 to 110.9). No significant differences were found for PINP at week 4 or 12.

conclusionsBone turnover markers were significantly reduced with branded and generic alendronate. With branded, CTX was significantly lower at 4 weeks. Generic caused significantly higher abdominal pain scores in the first 4 weeks of treatment. Therefore, generic alendronate may not have the same tolerability and efficacy as branded alendronate in the first weeks after starting treatment in patients with a recent fracture.

trial registrationDutch Trial Register NTR number 1867 http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=1867.

Indexed as

AgedAlendronateBone Density Conservation AgentsCross-Over StudiesDouble-Blind MethodDrugs, GenericFemaleFractures, BoneHumansMiddle AgedOsteoporosis, PostmenopausalAlendronateBone Density Conservation AgentsDrugs, Generic

Identifiers

PMID24205135
PMCPMC3804551
OpenAlexW1986426837

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.